Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005121 |
| Other study ID # |
900 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
April 13, 2016 |
| Start date |
July 1948 |
| Est. completion date |
September 2008 |
Study information
| Verified date |
April 2009 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
The Framingham Heart Study was initiated to study the factors associated with the
development of cardiovascular disease by employing long-term surveillance of an adult
population in Framingham, Massachusetts. The Framingham Offspring Study was initiated to
assess familial and genetic factors as determinants of coronary heart disease.
Description:
BACKGROUND:
The Framingham Heart Study, initiated in 1948, was designed as a longitudinal investigation
of constitutional and environmental factors influencing the development of cardiovascular
disease in men and women free of these conditions at the outset. The first person was
examined in September 1948 and four years later 5,209 persons had received their first
examination. The group has now been followed in the Study for twenty-four subsequent
biennial examinations. The need for more information arises from the fact that the
epidemiology of cardiovascular disease is incompletely known, estimation of risk is
imprecise, and the pattern of cardiovascular disease incidence is changing; these changes
need to be documented. Changing patterns of cigarette smoking, nutritional habits and
exercise patterns as well as changes in other aspects of lifestyle and advances in medical
care may all influence future morbidity and mortality rates for cardiovascular disease. New
cases of clinically recognizable cardiovascular disease are less predictable in disease free
subjects over age 60, and an already large and growing proportion of the total
cardiovascular disease events is now first expressed at these ages. Recently available,
technologically advanced measurement tools such as echocardiography need to be evaluated as
risk assessors in various age groups. Similarly, the predictive efficacy of recently
available lipoprotein cholesterol and apoprotein measurements need to be demonstrated for
early onset (age less than 60) as well as later onset cardiovascular disease. Thus, as
changes in early detection and treatment of cardiovascular disease advance, prospective
epidemiology is needed to document the value and impact of these changes in an organized
fashion. Finally, the availability of prospective data on two generations adds to the
uniqueness of the Framingham Study among ongoing studies of CVD epidemiology. A
determination of the extent and mechanisms by which cardiovascular diseases cluster in
families is another important goal of the Framingham Study.
In 1982, the National Institute on Aging initiated a study on senile dementia using the
Framingham Heart Study cohort. The study was designed to determine morbidity and mortality
outcomes among the 160 subjects identified as suffering from dementia at the 15th biennial
examination and to determine incidence of senile dementia among those subjects free of
dementia at the 15th biennial examination. Outcome of nursing home admissions was also
determined in all study participants.
Biennial comprehensive examinations of the Framingham Heart Study cohort have taken place
since 1949. Until examination 12, the study was carried out entirely by the NHLBI. After
that time, the Boston University Medical Center, in collaboration with, and using facilities
and equipment made available by NHLBI, was responsible for the examinations.
DESIGN NARRATIVE:
Biennial examinations are conducted in the surviving original cohort to obtain information
on physical activity, blood pressure, diet, body weight, occupational history, psychosocial
factors, and personal habits such as smoking. Special tests include electrocardiographic
evaluation, exercise stress test, HLA typing, lipoprotein and apoprotein testing,
non-invasive assessment of atherosclerosis, fasting blood glucose, lung function testing,
B-scan/Doppler of the carotid and or femoral arteries, and clotting or hemostatic measures.
Endpoints include coronary heart disease, stroke, hypertension, congestive heart failure,
and peripheral arterial disease.
Members of the Offspring Study were examined for the first time between 1971 and 1975, for
the second time between 1979 and 1983, for the third time between 1983 and 1987.
Examinations consist of a complete physical examination including resting electrocardiogram,
medical history, non-invasive cardiovascular examination, lung function assessment,
lipoprotein cholesterol and apoprotein measurements, SMA 25, personal history interview,
blood cell ion flux measurement, and platelet function and blood clotting factors
measurement.
The 27th exam of approximately 400 survivors of the original cohort is complete. The 28th
exam has begun and is ahead of schedule. The 7th exam of the Offspring Cohort began in
September 1998 and was completed in December 2001 with 3,500 participants examined. The
genome scan is complete with approximately 1,800 samples from 336 families. A Genetics
Advisory Panel meets regularly to advise NHLBI on the direction of genetic research within
the Framingham Study. Analysis of the genetic and nongenetic data is ongoing and extensive
covering such areas as the genetics of lipids, lifetime risk of coronary heart disease,
trends in events following Q-wave myocardial infarction, factors affecting left ventricular
hypertrophy, and the prevalence and determinants of heart valve disorders.
Initiation of the Third Generation Study was announced in November 2001. Beginning in 2002,
the Third Generation Study enrolled 3,900 grandchildren of the Framingham Heart Study's
original enrollees. Key goals are to identify new risk factors for heart, lung, and blood
diseases, identify genes that contribute to good health and to the development of heart,
lung, and blood disease, and to develop new imaging tests that can detect very early stages
of coronary atherosclerosis in otherwise healthy adults.
